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CONTEC08C Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult individuals.

The proposed device, CONTEC08C Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. The device can automatically complete the inflation, deflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. It can be only used on adult individuals.

The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.

The device has technical alarm function which will be triggered when the battery voltage is lower than 3.7V, and this alarm can not be cancelled unless being closed or the power replaced.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTEC08C Electronic Sphygmomanometer:

The provided document describes the clearance of a non-invasive blood pressure monitor (sphygmomanometer) through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally relies on performance testing against recognized standards rather than extensive clinical efficacy studies typically seen for novel devices.

Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed against the recognized standard ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006. This standard outlines requirements for automatic sphygmomanometers, including accuracy specifications.

Note: The provided text states that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ... ANSI/AAMI SP10: 2002 & A1: 2003 & A2: 2006." While it confirms compliance, specific numerical performance results (e.g., the exact mean difference and standard deviation achieved) are not detailed in this summary. However, meeting ANSI/AAMI SP10 implicitly means meeting its accuracy requirements for blood pressure (mean difference ≤ ±5 mmHg and standard deviation ≤ 8 mmHg).

Study Details

Given the nature of a 510(k) for a sphygmomanometer tested against ANSI/AAMI SP10, the "study" referred to is a specific blood pressure accuracy validation protocol as defined by that standard.

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not explicitly state the number of subjects (the sample size) used for the blood pressure accuracy testing according to ANSI/AAMI SP10. The standard itself specifies minimum subject requirements for various test phases (e.g., 85 subjects for the clinical validation of accuracy).
   • Data Provenance: The document states that "Bench tests were conducted." The sponsor and submission correspondent are based in China (CONTEC MEDICAL SYSTEMS CO., LTD and Mid-Link Consulting Co., Ltd.), which suggests the testing was likely conducted in China. The data is prospective, meaning it was collected specifically for the purpose of validating the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For blood pressure validation, the "ground truth" is typically established by trained observers (auscultators) using a mercury sphygmomanometer or validated reference device according to a standardized protocol. ANSI/AAMI SP10 requires at least two trained observers to simultaneously obtain reference blood pressure measurements.
   • Qualifications of experts: These observers must be specifically trained and certified as competent in auscultatory blood pressure measurement. While the document doesn't detail their specific qualifications, compliance with ANSI/AAMI SP10 implies that appropriately qualified personnel were used.

3. Adjudication method for the test set:

   • ANSI/AAMI SP10 specifies an adjudication method for observer differences. Typically, if the two observers' readings differ by more than a predefined amount (e.g., 4 mmHg), a third observer or a re-measurement may be required, or the data point may be discarded. The exact protocol would follow the standard.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is an automatic electronic sphygmomanometer and does not involve "human readers" interpreting images or data with or without AI assistance in the way an MRMC study would apply. Its function is to provide direct measurements. Therefore, an MRMC comparative effectiveness study was not performed and is not applicable here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the primary testing described is a standalone performance test of the device. The device's algorithm (oscillometric technique) measures blood pressure automatically without human input during the measurement phase. The "bench tests" and compliance with ANSI/AAMI SP10 are evaluations of this standalone performance.

6. The type of ground truth used:

   • For blood pressure devices, the ground truth is expert auscultatory measurements (or another validated reference method) conducted concurrently with the device measurements on human subjects, as dictated by the ANSI/AAMI SP10 standard.

7. The sample size for the training set:

   • The document does not refer to a distinct "training set" for an algorithm to be learned or optimized in the sense of machine learning. The device utilizes an oscillometric algorithm which is a well-established technique for blood pressure measurement. Any internal calibration or algorithm refinement by the manufacturer would have been part of the device's design and development, not typically described as a "training set" in a 510(k) summary for such a device. The testing described is validation of the final device.

8. How the ground truth for the training set was established:

   • As there is no "training set" explicitly mentioned or applicable in the context of an AI/machine learning model as typically discussed, this question is not relevant to the provided information. The device's underlying algorithm is based on established oscillometric principles rather than a data-driven "training" process from a ground truth dataset in the AI sense.

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CONTEC08A Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

The proposed device, CONTEC08A Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation, deflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can be used on adult, pediatric, and neonatal individuals.

The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.

CONTEC08A has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, the device has technical alarm function which will be triggered when the battery voltage is lower than 3.9V, and this alarm can not be cancelled unless being closed or the power replaced.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CONTEC08A Electronic Sphygmomanometer are based on the ANSI/AAMI SP10:2002 & A1:2003 & A2:2006 standard for manual, electronic, or automated sphygmomanometers. While the specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text, the document confirms that "The test results demonstrated that the proposed device comply with the standard requirements and the accuracy the manufacture declared."

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text.
• Data Provenance: The clinical test was conducted in Qinhuangdao Maternal and Child Health Hospital, China. This indicates a prospective clinical study conducted in China.

3. Number of Experts and Qualifications

Not explicitly stated in the provided text. The document mentions "clinical test following ANSI/AAMI SP10," but does not detail the involvement or qualifications of experts in establishing ground truth.

4. Adjudication Method

Not explicitly stated in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The provided text describes a clinical test for an automatic non-invasive blood pressure monitor, not a study evaluating human readers' performance with or without AI assistance.

6. Standalone Performance

Yes, a standalone performance evaluation was conducted. The clinical test evaluated the device's accuracy against the ANSI/AAMI SP10 standard. The device "can automatically complete the inflation, deflation and BP measurement," indicating its standalone capability.

7. Type of Ground Truth Used

The type of ground truth used is implied to be a reference standard for blood pressure measurement, as mandated by the ANSI/AAMI SP10 standard. This standard typically involves comparisons to auscultatory reference measurements performed by trained observers.

8. Sample Size for Training Set

Not applicable. This device is an automatic sphygmomanometer, and the description of its testing focuses on clinical validation rather than a machine learning model that would require a distinct training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no mention of a training set for a machine learning model.

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